NCT01661231

Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe

BIOTRONIK - The Treatment of Iliac and Femoral Atherosclerotic Lesions Using the Self-expanding Astron and Pulsar-18 Stents (BIOFLEX-I Europe)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

Conditions

• Peripheral Artery Disease
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Astron/Pulsar-18 stent	Peripheral Vascular Intervention

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-09-01
• Completion: 2018-10-01
• First posted: 2012-08-09
• Last updated: 2017-02-03

Locations

7 sites across 4 countries: Austria, Belgium, Germany, Switzerland